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Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
The purpose of this study is to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers. The preference study is designed to elicit patient preferences for risks and features that vary between a dual chamber leadless pacemaker system and a dual chamber transvenous pacemaker system, to quantify their relative importance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Preference Survey | Other | Patient preference survey on implantable cardiac pacemaker systems |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Rankings for Pacemaker Device Features | Ranking of six pacemaker device features from most concerning (1) to least concerning (6) | Baseline |
| Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | The preference weights for the RPL model. Effect-coded parameters generate log-odds preference weights representing the relative strength of preference for each attribute level versus the mean effect across levels normalized at zero. A higher weight indicates a more preferred level while a lower weight indicates a less preferred level. | Baseline |
| Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity. | Baseline |
| Maximum-acceptable Risks of a Complication | Maximum-acceptable risk (MAR) of a complication was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represents risk level patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval. | Baseline |
| Maximum-acceptable Risks of an Infection | Maximum-acceptable risk (MAR) of an infection was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represent the risk that patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval. |
| Measure | Description | Time Frame |
|---|---|---|
| Constrained 2-class Latent-class Model Preference Weights | Latent-class (LC) analysis was used to identify systematically different preference patterns across respondents. LC analysis provides a unique set of estimates of preference weights for a prespecified number of preference classes. Respondents are probabilistically assigned to classes based on the similarity of their responses to the overall preference pattern identified in each class. |
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Inclusion Criteria:
Exclusion Criteria:
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300 patients
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| Name | Affiliation | Role |
|---|---|---|
| Shelby Reed, PhD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health | Scottsdale | Arizona | 85258 | United States | ||
| Arrhythmia Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39569505 | Derived | Reed SD, Yang JC, Wallace MJ, Sutphin J, Johnson FR, Ozdemir S, Delgado SM, Goates S, Harbert N, Lo M, Rajagopalan B, Ip JE, Al-Khatib SM. Patient Preferences for Features Associated With Leadless Versus Conventional Transvenous Cardiac Pacemakers. Circ Cardiovasc Qual Outcomes. 2024 Dec;17(12):e011168. doi: 10.1161/CIRCOUTCOMES.124.011168. Epub 2024 Nov 21. |
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Patients were recruited from Aveirâ„¢ DR IDE trial study sites. One-hundred seventeen patients were recruited and completed the survey instrument.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Preferences Survey | Patients were recruited from Aveirâ„¢ DR IDE trial study sites. To minimize selection bias, patients meeting the criteria listed above and agreeing to participate were asked to complete the patient-preference survey before being approached about their potential interest in enrolling in the IDE trial. Thus, they completed the patient-preference survey before they received information about dual-chamber pacemakers from the site physician and/or the Aveirâ„¢ DR IDE study and before they received a pacemaker if they ultimately received one. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Preferences Survey | Patients were recruited from Aveirâ„¢ DR IDE trial study sites. To minimize selection bias, patients meeting specified criteria and agreeing to participate were asked to complete the patient-preference survey before being approached about their potential interest in enrolling in the IDE trial. Thus, they completed the patient-preference survey before they received information about dual-chamber pacemakers from the site physician and/or the Aveirâ„¢ DR IDE study and before they received a pacemaker if they ultimately received one. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Rankings for Pacemaker Device Features | Ranking of six pacemaker device features from most concerning (1) to least concerning (6) | Each respondent was asked to rank the six features (insertion procedure, pacemaker type, pacemaker location, no heavy lifting, scar on chest, and lump on chest) from most concerning (1) to least concerning (6). The table reports the mean ranking for each device feature evaluated on a scale from 1-6. The number of respondents is 90 because 27 respondents skipped the ranking questions | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Serious and other [non-serious] adverse events were not collected or assessed as part of the study
Serious and other [non-serious] adverse events were not collected or assessed as part of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Preferences Survey | Patients were recruited from Aveirâ„¢ DR IDE trial study sites. To minimize selection bias, patients meeting the criteria listed above and agreeing to participate were asked to complete the patient-preference survey before being approached about their potential interest in enrolling in the IDE trial. Thus, they completed the patient-preference survey before they received information about dual-chamber pacemakers from the site physician and/or the Aveirâ„¢ DR IDE study and before they received a pacemaker if they ultimately received one. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Delgado | Abbott Medical Devices | 818-493-3285 | stephanie.delgado1@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2022 | Jun 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2021 | Jun 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline |
| Probability of Choosing Specified Pacemakers - All 3 Profiles | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable, leadless pacemaker non-removable, or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Baseline |
| Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or leadless pacemaker non-removable. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Baseline |
| Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Baseline |
| Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker non-removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Baseline |
| Baseline |
| Number of Discrete Choice Experiment Questions Answered | Number of Discrete choice experiment (DCE) questions answered by 117 respondents who answered at least the first 8 DCE questions. After respondents answered 8 DCE questions, they were asked if they would like to complete 4 additional questions. | Baseline |
| Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Respondent characteristics can be associated with class membership probabilities to "profile" the classes. These results show if respondents with certain characteristics are more likely to be in one class versus the other. The odds ratios of being in the transvenous class versus the leadless class for patient characteristics. Odds ratios greater than 1 indicate a higher likelihood of being in the class preferring transvenous pacemakers and pacemakers with longer time since government approval. | Baseline |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Pacific Heart Institute | Santa Monica | California | 90404 | United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Prairie Education & Research Cooperative | Springfield | Illinois | 62769 | United States |
| Charlton Memorial Hospital | Fall River | Massachusetts | 02720 | United States |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10021 | United States |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Health Insurance | Number | participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Employment | Count of participants selecting employment option. Participants allowed to select more than 1 option | Count of Participants | Participants |
|
| Race | Count of participants selecting race option. Participants were allowed to select more than 1 option | Count of Participants | Participants |
|
|
|
| Primary | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | The preference weights for the RPL model. Effect-coded parameters generate log-odds preference weights representing the relative strength of preference for each attribute level versus the mean effect across levels normalized at zero. A higher weight indicates a more preferred level while a lower weight indicates a less preferred level. | Posted | Number | preference weights | Baseline |
|
|
|
| Primary | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity. | Posted | Number | standard deviation | Baseline |
|
|
|
| Primary | Maximum-acceptable Risks of a Complication | Maximum-acceptable risk (MAR) of a complication was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represents risk level patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval. | Posted | Number | 95% Confidence Interval | percentage of maximum-acceptable risk | Baseline |
|
|
|
| Primary | Maximum-acceptable Risks of an Infection | Maximum-acceptable risk (MAR) of an infection was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represent the risk that patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval. | Posted | Number | 95% Confidence Interval | percentage of maximum-acceptable risk | Baseline |
|
|
|
| Primary | Probability of Choosing Specified Pacemakers - All 3 Profiles | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable, leadless pacemaker non-removable, or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Posted | Number | 95% Confidence Interval | percentage of probability | Baseline |
|
|
|
| Primary | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or leadless pacemaker non-removable. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Posted | Number | 95% Confidence Interval | percentage of probability | Baseline |
|
|
|
| Primary | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Posted | Number | 95% Confidence Interval | percentage of probability | Baseline |
|
|
|
| Primary | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker non-removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. | Posted | Number | 95% Confidence Interval | percentage of probability | Baseline |
|
|
|
| Secondary | Constrained 2-class Latent-class Model Preference Weights | Latent-class (LC) analysis was used to identify systematically different preference patterns across respondents. LC analysis provides a unique set of estimates of preference weights for a prespecified number of preference classes. Respondents are probabilistically assigned to classes based on the similarity of their responses to the overall preference pattern identified in each class. | Posted | Number | percentage of participants | Baseline |
|
|
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| Secondary | Number of Discrete Choice Experiment Questions Answered | Number of Discrete choice experiment (DCE) questions answered by 117 respondents who answered at least the first 8 DCE questions. After respondents answered 8 DCE questions, they were asked if they would like to complete 4 additional questions. | Posted | Count of Participants | Participants | Baseline |
|
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| Secondary | Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Respondent characteristics can be associated with class membership probabilities to "profile" the classes. These results show if respondents with certain characteristics are more likely to be in one class versus the other. The odds ratios of being in the transvenous class versus the leadless class for patient characteristics. Odds ratios greater than 1 indicate a higher likelihood of being in the class preferring transvenous pacemakers and pacemakers with longer time since government approval. | Posted | Number | odds ratio | Baseline |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Title | Measurements |
|---|---|
|
| Battery life - 15 years |
|
| Battery life - 12 years |
|
| Battery life - 8 years |
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| Battery life - 5 years |
|
| Time since regulatory approval - 10 years |
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| Time since regulatory approval - 2 years |
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| Discomfort for 6 months - No discomfort |
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| Discomfort for 6 months - Discomfort |
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| Risk of Complication - 1% |
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| Risk of Complication - 5% |
|
| Risk of Complication - 10% |
|
| Risk of Complication - 20% |
|
| Risk of infection - 1% |
|
| Risk of infection - 5% |
|
| Risk of infection - 10% |
|
| Risk of infection - 20% |
|
| Title | Measurements |
|---|---|
|
| Battery life - 15 years |
|
| Battery life - 12 years |
|
| Battery life - 8 years |
|
| Battery life - 5 years |
|
| Time since regulatory approval - 10 years |
|
| Time since regulatory approval - 2 years |
|
| Discomfort for 6 months - No discomfort |
|
| Discomfort for 6 months - Discomfort |
|
| Risk of Complication - 1% |
|
| Risk of Complication - 5% |
|
| Risk of Complication - 10% |
|
| Risk of Complication - 20% |
|
| Risk of infection - 1% |
|
| Risk of infection - 5% |
|
| Risk of infection - 10% |
|
| Risk of infection - 20% |
|
| Patients in leadless class willing to accept MAR for transvenous rather than removable leadless |
|
| Patients in transvenous class willing to accept MAR for transvenous rather than removable leadless |
|
| Patients in leadless class willing to accept MAR for transvenous rather than nonremovable leadless |
|
| Patients in transvenous class willing to accept MAR for transvenous instead of nonremovable leadless |
|
| Patients in leadless class willing to accept MAR for removable rather than nonremovable leadless |
|
| Patients in transvenous class willing to accept MAR for removable rather than nonremovable leadless |
|
| Transvenous class patients willing to accept MAR for 10 yrs since government approval rather than 2 |
|
| Leadless class patients willing to accept MAR for 10 yrs since government approval rather than 2 |
|
| Leadless & transvenous class patients willing to accept MAR for 15 yrs of battery life instead of 2 |
|
| Leadless & transvenous class patients willing to accept MAR for no discomfort rather than discomfort |
|
| Patients in leadless class willing to accept MAR for transvenous rather than removable leadless |
|
| Patients in transvenous class willing to accept MAR for transvenous rather than removable leadless |
|
| Patients in leadless class willing to accept MAR for transvenous rather than nonremovable leadless |
|
| Patients in transvenous class willing to accept MAR for transvenous instead of nonremovable leadless |
|
| Patients in leadless class willing to accept MAR for removable rather than nonremovable leadless |
|
| Patients in transvenous class willing to accept MAR for removable rather than nonremovable leadless |
|
| Transvenous class patients willing to accept MAR for 10 yrs since government approval rather than 2 |
|
| Leadless class patients willing to accept MAR for 10 yrs since government approval rather than 2 |
|
| Leadless & transvenous class patients willing to accept MAR for 15 yrs of battery life instead of 2 |
|
| Leadless & transvenous class patients willing to accept MAR for no discomfort rather than discomfort |
|
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| Probability transvenous class to choose profile: leadless pacemaker non-removable |
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| Probability leadless class to choose profile: pacemaker with leads |
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| Probability transvenous class to choose profile: pacemaker with leads |
|
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| Probability transvenous class to choose profile: leadless pacemaker non-removable |
|
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| Probability transvenous class to choose profile: pacemaker with leads |
|
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| Probability transvenous class to choose profile: pacemaker with leads |
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| Title | Measurements |
|---|---|
|
| Major surgery requiring hospitalization in the last 5 years |
|
| Sedentary lifestyle with light activity |
|
| Interaction of lifestyle and BMI |
|